User`s Manual
Contents
1. BREAST Q USERS MANUAL VERSION 1 0 JULY 2012 Information in this document is subject to change without notice Complying with all applicable copyright laws is the responsibility of the user No part of this document may be reproduced or transmitted on any form or by any means electronic or mechanical for any purpose without the express written permission of Memorial Sloan Kettering Cancer Center Copyright 2012 Memorial Sloan Kettering Cancer Center Printing History July 2012 Version 1 0 Trademarks BREAST Q is a registered trademark Other products and company names mentioned herein may be the trademarks of their respective owners While every precaution has been taken in the preparation of this Manual the publisher assumes no responsibility for errors or omissions or for damages resulting from the use of information contained herein Installation Installation of Q Score and accompanying manual is permitted from http webcore mskcc org breastq scoreBQ html onto as many PC s as the number of licences permit as described in the Licence Details Certificate Copying Copying or altering any parts of the BREAST Q or Q Score is not permitted BREAST Q User Manual Version 1 0 July 2012 Table of Contents I What 18 th BREAST Q scsissssecstinsicdsccsseleciadnsacasbcontaishendoosacpovacasesbecossenssabiseoncnavespoucsueecsdsatabeseriasoncs 3 1 1 BREAST Q AUGMENTATION MODULE 1 sccssscscssscscssscscssscccssccccss2. Save as type Text files txt 2 CJ 6 Start the QScore program 7 Select the desired questionnaire version from the Questionnaire drop down list Questionnaire Augmentation Post Input File Reconstruction Post Browse Input File Augmentation Pre Reconstruction Pre Reduction Pre www BREAST Q org BREAST Q User Manual Version 1 0 July 2012 8 Next click Browse Input File and locate the text file you would like to import P QScore DERK Questionnaire Augmentation Post v Input File Browse Input r 9 QScore will automatically score and display the results in an internal spread sheet Questionnaire Augmentation Post v Input File F Breast Manual ugmentation Breast ForScoring txt Browse Input File gt 100 s gt 101 amp 110 z 10 o 25 103 10 8 10 104 38 70 J 42 8 amp 10 10 10 Select Export Scores at the bottom of the program window 105 34 5 359 5 5 5 90 105 43 42 100 10 107 5 1 85 80 Output File www BREAST Q org BREAST Q User Manual Version 1 0 July 2012 a Name the file with the xls extension 1 for exam
3. comfortable the woman was made to feel and whether she felt she was treated in a respectful manner www BREAST Q org BREAST Q User Manual Version 1 0 July 2012 1 4 BREAST Q RECONSTRUCTION MODULE APPENDIX 5 amp 6 QUALITY OF LIFE DOMAINS 1 Psychosocial Well being This scale measures psychosocial well being with items that ask about body image e g accepting of body attractive and a woman s confidence in social settings Other items cover emotional health and self esteem 2 Sexual Well being This scale measures sexual well being and body image issues with items that ask about feelings of sexual attractiveness when clothed and unclothed and sexual confidence as it relates to one s breasts as well as how comfortable or at ease a woman feels during sexual activity 3 Physical Well being a Chest and Upper Body This scale measures physical problems such as pain e g neck back shoulder arm rib and problems in the breast area e g tightness pulling tenderness pain Other items ask about activity limitations and sleep problems due to discomfort b Abdomen and Trunk This scale measures negative physical sequelae of the abdomen following autologous tissue reconstruction TRAM or DIEP flap Items cover abdominal discomfort bloating bulging and pain as well as difficulty doing certain activities due to abdominal weakness SATISFACTION DOMAINS 1 Satisfaction with Breasts This scale measures body image in te
4. healing and recovery time how the breast s would look implications for future breast cancer screening how the surgery would be done and breast appearance e g breast size scars b Surgeon This scale measures satisfaction with the surgeon Items ask about the surgeon s manner e g professional reassuring thorough sensitive and communication skills e g easy to talk to Items also cover the extent to which the patient was involved in the decision making www BREAST Q org BREAST Q User Manual Version 1 0 July 2012 and understood the process c Medical team This scale measures satisfaction with members of the medical team other than surgeon Items ask whether the staff were professional knowledgeable and friendly as well as how comfortable the woman was made to feel and whether she felt she was treated in a respectful manner d Office Staff This scale measures satisfaction with interactions with members of the office staff Items ask whether staff were professional knowledgeable and friendly as well as how comfortable the woman was made to feel and whether she felt she was treated in a respectful manner EXPECTATION DOMAINS These scales are designed to be administered pre operatively and assess patient expectations for the process and outcome of surgery The expectations scales compliment the satisfaction and quality of life domains of the post operative reconstruction module Multi item and categorical scale st
5. 0 July 2012 Table 1 Description of the BREAST Q modules 1 Augmentation module Pre operative 25 items Post operative 88 items 2 Reduction Mastopexy module Pre operative 39 items Post operative 93 items 3 Mastectomy module Pre operative 37 items Post operative 63 items 4 Reconstruction module Pre operative 42 items o Post operative 116 items Expectations for Reconstruction scales Pre operative 42 items Total number of items 4 point Likert like scales from 1 Very dissatisfied to 4 Very satisfied 3 point Likert like scales from 1 disagree to 3 Definitely agree Response scale s 5 point Likert like scales from 1 None of the time to 5 of the time Not applicable 4 point Likert like scales from Definitely disagree to 4 Definitely agree Self administered paper and pencil Mode chadministration Electronic in development Varies based on the number of scales completed in each module Augmentation Module all scales 8 10 minutes Reconstruction Module all scales 10 14 minutes Reduction Module all scales 10 12 Mastectomy Module all scales 10 12 minutes Time for completion Inthe past 2 weeks Anexception to this rule is the Sexual Well being scale which has no Recall period recall period in the preoperative period In the postoperative module the recall period is since the su
6. 4 optimized for fast loading and saving PsychoSocial Well being 4 Sexual Well being Excel 97 2003 Workbook 45 42 El Save a copy of the workbook that is fully 28 33 compatible with Excel 97 2003 f 45 25 File name ScoredBreastQ xls v Save as type Excel 97 2003 Workbook xls 3 Tools M Save Cancel 2 www BREAST Q org BREAST Q User Manual Version 1 0 July 2012 4 Interpretation All BREAST Q scores range from 0 100 The scores are computed from the responses to the separate questions by adding them together and converting the score to a scale from 0 to 100 similar to conversion into a percentage A higher score means high satisfaction or better health related quality of life The clinical meaning of BREAST Q scores and the smallest clinically significant differences are not yet defined research is ongoing However the interpretation of the clinical significance of BREAST Q scores is facilitated by the recently available data from a study of 2000 patients at Memorial Sloan Kettering Cancer Center in New York USA The mean values of QL scores in the general population are indicated with an arrow on the printout to serve as a rough guide for the severity of the limitations symptoms A study of the subjective significance to the patients of changes in QL scores suggests that a mean change of 5 to 10 on the multi item scales is perceived as a little change 10 to 20 as a moderate change a
7. PL Klassen AF Scott A McCarthy C Cano S Measuring patient outcomes after breast augmentation Introducing the BREAST Q Augmentation Module Clin Plast Surg 2009 Jan 36 1 23 32 Klassen A Pusic AL Scott A Klok J Cano S Satisfaction and quality of life in women who undergo breast surgery A qualitative study BMC Women s Health 2009 May 1 9 11 Pusic AL Klassen A Scott A Klok J Cordeiro PG Cano SJ Development of a New Patient Reported Outcome Measure for Breast Surgery The BREAST QO Plast Reconstr Surg 2009 Aug 124 2 345 53 Chen CM Cano SJ Klassen AF King T McCarthy C Cordeiro PG Morrow M Pusic AL Measuring quality of life in oncologic breast surgery a systematic review of patient reported outcome measures Breast J 2010 Nov Dec 16 6 587 97 Cano SJ Klassen AF Pusic AL From BREAST QO to Q ScoreO Using Rasch Measurement to Better Capture Breast Surgery Outcomes Joint International IMEDO TCI TC7 TC13 Symposium 2011 Aug 31 Sept 2 Jena Germany urn nbn de gbv ilm1 201 limeko 2 Cano SJ Klassen AF Scott AM Cordeiro PG Pusic AL The BREAST Q Further Validation in Independent Clinical Samples Plast Reconstr Surg 2012 Feb 129 2 293 302 Pusic AL Klassen AF Snell L Cano SJ McCarthy C Scott A Cemal Y Rubin LR Corderio PG Measuring and managing patient expectations for breast reconstruction impact on quality of life and patient satisfaction Expert Rev Pharmacoecon Outcomes Res 2012 Apr 12
8. Slovenian applicable Swedish pu E applicable Mandarin Not Chinese for applicable the US Czech E a Nol applicable Malay for Not Australia applicable denotes academic translations supervised by MAPI institute There are no current translations for the Reduction mastopexy module or the Mastectomy module www BREAST Q org BREAST Q User Manual Version 1 0 July 2012 7 Conditions of Use The Memorial Sloan Kettering Cancer and the University of British Columbia hold the copyright of the BREAST Q and all its translations past on going and future To avoid any copyright infringement a copyright notice shall be included on the original questionnaire and all its derivatives including but not limited to translations as follows Memorial Sloan Kettering Cancer Center and The University of British Columbia 2006 All rights reserved Use of the BREAST Q questionnaire requires completion of a User s agreement with MAPI Research Trust For permission to use the BREAST Q please contact MAPI trust at PROinformation mapi trust org The use of the BREAST Q and its modules in non profit academic research and in clinical care is free of charge The use of the BREAST Q by for profit organizations is subject to a fee per module per protocol For questions regarding fees to be paid by for profit organizations please contact Yashodhara Dash M B B S
9. psychometric properties of BREAST Q scales The second is that by adding items the scale can no longer be scored making it impossible to compare findings with those of other BREAST Q studies Finally altering the BREAST Q by adding items is prohibited under copyright laws You may have however ask any additional questions that you wish as long as they are separate from the BREAST Q scales You can t consider these questions to be part of the BREAST Q Which module do I use for oncoplastic procedures For oncoplastic surgery procedures the BREAST Q Reduction Mastopexy module and the BCT module are recommended depending on the exact nature of the procedure i e for oncoplastic breast reduction use Reduction module for oncoplastic lumpectomy glandular remodelling use BCT module For patients www BREAST Q org BREAST Q User Manual Version 1 0 July 2012 Which module do I use for fat grafting procedures For patients undergoing fat grafting procedures either the BREAST Q Reconstruction or Augmentation modules may be used depending on the indications for the procedure i e correction of defect following oncologic resection or cosmetic augmentation Frequently Asked Questions Translation of the BREAST Q Can I translate the BREAST Q into a new language For translation of the BREAST Q scales contact MAPI research trust This organization will provide you with a current list of available languages of each module and if a language is no
10. 2 149 58 Publications using the BREAST Q Hu ES Pusic AL Waljee JF Kuhn L Hawley ST Wilkins E Alderman AK Patient reported aesthetic satisfaction with breast reconstruction during the long term survivorship period Plast Reconstr Surg 2009 Jul 124 1 1 8 Macadam SA Ho AL Cook EK Jr Lennox PA Pusic AL Patient satisfaction and health related quality of life following breast reconstruction A comparison of patient reported outcomes amongst saline and silicone implant recipients Plast Reconstr Surg 2010 Mar 125 3 761 71 McCarthy C Klassen AK Cano SJ Scott A VanLaeken N Lennox PA Alderman AK Mehrara BJ Disa JJ Cordeiro PG Pusic AL Patient Satisfaction with Postmastectomy Breast Reconstruction A Comparison of Saline and Silicone Implants Cancer 2010Dec 116 24 5584 91 www BREAST Q org BREAST Q User Manual Version 1 0 July 2012 Salgarello M Rochira D Barone Adesi L Farallo E Immediate Breast Reconstruction After Skin or Nipple Sparing Mastectomy for Previously Augmented Patients A Personal Technique Aesthetic Plast Surg 2011 Sep 10 Goyal A Wu JM Chandran VP Reed MW Outcome after autologous dermal sling assisted immediate breast reconstruction Br J Surg 2011 Sep 98 9 1267 72 Salgarello M Visconti G Barone Adesi L Fat Grafting and Breast Reconstruction with Implant Another Option for the Irradiated Breast Cancer Patients Plast Reconstr Surg 2011 Oct 18 Zhong T McCarthy C Min S Zhan
11. Ph D M B A Licensing Associate Office of Technology Transfer Memorial Sloan Kettering Cancer Center 1275 York Avenue New York NY 10065 dashy mskcc org For questions regarding study design and optimal use of BREAST Q scales please see www breastq org or contact Andrea Pusic MD MHS FACS FRCSC Memorial Sloan Kettering Cancer Center 1275 York Avenue New York NY 10065 pusica mskcc org www BREAST Q org BREAST Q User Manual Version 1 0 July 2012 8 Frequently Asked Questions Frequently Asked Questions Ethics board IRB approval Do I need local ethics board IRB approval If your intent is to collect BREAST Q data for research purposes a local ethics board must review your methods patient recruitment consent and privacy If you are administering the BREAST Q for clinical care ethics board approval is generally not required If in doubt contact your local ethics board Frequently Asked Questions How to use the BREAST Q Do I have to use all the scales No you do not have to use all scales Patients can be asked to complete some or all of a module s BREAST Q scales It is not necessary for a patient to complete all of the scales within a module as there is no overall or total BREAST Q score A researcher or clinician may therefore select a subset of scales depending on the particular purpose of the study or use Can I delete any items in the BREAST Q No you cannot delete any items ina BREAST Q scale Any m
12. Q scales A researcher or clinician may therefore select a subset of scales depending on purpose of the particular study or use As an example in a quality improvement program the 4 scales evaluating Satisfaction with Care might be used Satisfaction with Information with Surgeon with Medical Team with Office Staff Alternatively the Satisfaction with Breast scale might be used alone in a study to evaluate a new breast surgery technique There is no overall or total BREAST Q score only scores for each independent scale Each module of the BREAST Q has both pre operative and post operative versions The post operative version includes all the pre operative items in addition to items that address unique postoperative issues e g scars The preoperative and postoperative scales are linked psychometrically to measure change Women may complete the pre operative questionnaire at any time prior to surgery baseline assessment and the post operative questionnaire at any time point after surgery follow up data The BREAST Q may also be administered at a single time point as in a cross sectional survey Each researcher or clinician may decide the time points at which he she would like to administer the scales Of note the BREAST Q Reconstruction Module Expectations scales differ in that they are designed for pre operative administration only For more information please also see www BREAST Q org www BREAST Q org BREAST Q User Manual Version 1
13. ary score for all the BREAST Q scales Instead each scale is independently scored BREAST Q scores are computed by using the Q Score program which is provided free of charge at www breast q org How do I enter missing data Missing data should be entered 99 in the appropriate scoring template If a response is left blank in the template the scoring software will give you an error message What do I do if a patient has selected more than one response to a question If the patient has selected more than one response to a question the patient has not responded properly to the question and the response should be scored as 88 in the appropriate scoring template to indicate the patient has responded with a double answer What do I do if a patient has selected not applicable or written not applicable on the questionnaire If the patient has indicated their response to a question is not applicable enter 66 in the appropriate scoring template www BREAST Q org BREAST Q User Manual Version 1 0 July 2012 www BREAST Q org BREAST Q User Manual Version 1 0 July 2012 9 Further Reading BREAST Q development and validation publications Pusic AL Chen CM Cano S Klassen A McCarthy C Collins ED Cordeiro PG Measuring quality of life in cosmetic and reconstructive breast surgery a systematic review of patient reported outcomes instruments Plast Reconstr Surg 2007 Sep 15 120 4 823 37 Pusic AL Reavey
14. ast Reconstruction Based on Patient Reported Outcome Measures and Health Related Quality of Life Ann Surg 2010 Aug 19 Cano S Klassen A F Scott A Thoma A Feeny D Pusic A Health outcome and economic measurement in breast cancer surgery challenges and opportunities Expert Rev Pharmacoecon Outcomes Res 2010 Oct 10 5 583 94 Morrow M Pusic AL Time for a new era in outcomes reporting for breast reconstruction J Natl Cancer Inst 2011 Jan 5 103 1 5 7 Epub 2010 Dec 3 Pusic AL Lemaine V Klassen AF Scott AM Cano SJ Patient reported outcome measures in plastic surgery use and interpretation in evidence based medicine Plast Reconstr Surg 2011 Mar 127 3 1361 7 www BREAST Q org
15. atisfaction with Outcome This scale measures a woman s overall appraisal of the outcome of her breast surgery Items cover whether the woman s expectations were met with respect to the aesthetic outcome and the impact surgery has had upon her life as well as satisfaction with the decision to have surgery e g I would do it again Satisfaction with Care a Information This scale measures satisfaction with information provided about breast augmentation surgery from the surgeon Items cover complications and risks e g implant leakage loss of nipple sensation capsular contracture rippling implications for future breast cancer screening and breast feeding healing and recovery time how the surgery would be done and breast appearance e g breast size scars b Surgeon This scale measures satisfaction with the surgeon Items ask about the surgeon s manner e g professional reassuring thorough sensitive and communication skills e g easy to talk to Items also cover the extent to which the patient was involved in the decision making and understood the process c Medical team This scale measures satisfaction with members of the medical team other than surgeon Items ask whether the staff were professional knowledgeable and friendly as well as how comfortable the woman was made to feel and whether she felt she was treated in a respectful manner d Office Staff This scale measures satisfaction with interactions with
16. being used in clinical practice and the patient does not wish to complete the questionnaire it is helpful to explain to the patient that BREAST Q data is being collected to provide their healthcare provider with a complete understanding of their health as it relates to breast surgery You can emphasize that the BREAST Q is quick and simple to complete What should I do if the patient does not want to answer to some or all of the questions If non completion is a result of the patient having trouble understanding a particular question ask her to explain why she had difficulty responding and read the question verbatim for them Do not rephrase the question If the patient is still unable to answer the question it is still possible to score a BREAST Q scale with missing data www BREAST Q org BREAST Q User Manual Version 1 0 July 2012 If the patient does not like a particular question or thinks it is unnecessary or inappropriate emphasize that she can write her comment on the BREAST Q and use all the space needed to express herself What should I do if the patient asks for clarification of a question While completing the BREAST Q some patients may ask for clarification of a particular question so that they can better understand and respond to it You can help by rereading the question verbatim but do not try to explain what the question means rather suggest that the patient uses her own interpretation of the question All patients should a
17. cccsescccssecccsssccessscseenes 6 1 2 BREAST Q REDUCTION MASTOPEXY MODULE 7 1 3 BREAST Q MASTECTOMY MODUL Bisssiccssscsssccseavsscctscessecseurecscuvesssesheivecnsassvesdcntevacdsevesadeodaes 8 1 4 BREAST Q RECONSTRUCTION MODULE cccsssssssssccssscccsssccesseccessccsesscscescsccssssecsssees 9 2 Administration of the BREAST Q cssccssssscssssccssssccsssscssssssssssssssssssssessssessssssesssssessssnesssseessosees 11 P OE ORE EPA DRE RDERO TER EX EP T Ie SEES DENDUM E 11 4 Interpretation Pone c 16 5 Technical eo sea eee eaae Coo cossbdacesasedocseesse 16 6 Translations 17 7 Conditions OF 19 8 Frequently Asked Questions 20 9 F ither Reading UR 24 www BREAST Q org BREAST Q User Manual Version 1 0 July 2012 1 What is the BREAST Q The BREAST Q is a patient reported outcome PRO instrument designed to evaluate outcomes among women undergoing different types of breast surgery There are currently four BREAST Q modules each of which is comprised of multiple scales 1 Augmentation 2 Reduction Mastopexy 3 Ma
18. ells within the data template Missing data or cells of unused scales should have a value of 99 entered A B Export to QScore il 2 3 4 100 2 2 5 101 2 39 6 8 3 G H J K li M Satisfaction with Breasts Values 1 4 88 99 are valid 2 2 2 99 99 99 99 99 99 2 99 99 2 2 99 99 99 102 39 39 103 99 99 104 39 38 105 2 2 I co Bro ro ro e on C e e e CO CO e e 99 www BREAST Q org BREAST Q User Manual Version 1 0 July 2012 4 Once you have entered all your BREAST Q data press the Export to QScore button in the upper left corner of the spread sheet This process will save the data in a tab delimited text file the required format for input to the QScore program A om m2 E e X K L M 1 Satisfaction with Breasts 2 Exportto QScore Gscore Values 1 4 88 99 are valid 5 4 100 2 2 2 2 2 2 2 2 2 2 2 s 101 2 98 2 2 2 2 2 2 2 2 39 B 102 98 99 2 2 98 2 2 99 99 2 99 7 103 99 99 99 99 99 99 99 99 99 99 99 8 104 99 99 2 2 99 2 99 2 39 2 2 9 105 2 2 2 99 2 2 99 2 2 39 39 5 Name your file 1 and click Save 2 to save it to your hard drive A dialog box will appear with the following message Data has been exported to chosen directory This file will now close and you may now open the txt file with the Scoring Utility File name 1 BreastQForScoring txt v
19. eview View Add Ins tye Calibri i Y Pc g Paste _ B xd Hes 9 650 00 Conditional Format gt u dos E Formatting as Table Sty Clipboard Font i Alignment m Number Styles Al G E B c 0 a 1 2 3 4 2 D 1 Satisfaction with Breasts 2 Satisfaction with Outcome 3 PsychoSocial Well being 4 Sexual Well being 3 100 37 100 45 42 4 101 33 86 28 33 5 102 37 61 45 25 6 103 N A 65 0 30 7 104 38 70 36 42 Save the spread sheet in an Excel format Saving the spread sheet in an Excel format will prevent the different format message you received upon opening the file To do this choose a The office button in Microsoft Excel 2007 File in previous versions of Excel b Select Save As c And the Excel format you want from the Save as type drop down list gt ScoredBreastQ xls Microsoft Excel View Add Ins General T d 1 569 588 28 Conditional Format Formatting as Table St Ta Number Styles Save a copy of the document R Excel Workbook TEH Save the file as an Excel Workbook Excel Macro Enabled Workbook TR Save the workbook in the XML based and macro enabled file format Excel Binary Workbook D al E ad Save the workbook in a binary file format 3
20. g BREAST Q User Manual Version 1 0 July 2012 For each subtheme one or more BREAST Q scales were developed to examine specific aspects of patient satisfaction and QOL For example the Satisfaction with Care theme has four separate scales that measure Satisfaction with Information Satisfaction with the Plastic Surgeon with the Medical Team and with Office Staff Across the various modules and patient treatment groups these scales are psychometrically linked and can thus be used for comparison between different patient groups Each BREAST Q scale is composed of a series of items or questions that evaluate a unidimensional construct The items that form each scale reflect a clinically relevant hierarchy As an example in the Reconstruction Module Satisfaction with Breasts scales items span a range from how satisfied are you with how you look in clothes to How satisfied are you when you see yourself in the mirror unclothed Patient responses to each scale s items are transformed through the Q Score scoring software described below to provide a total scale score that ranges from 0 to 100 For all BREAST Q scales a higher score means greater satisfaction or better QOL depending on the scale It is important to note that patients do not need to complete all BREAST Q scales in any given study or clinical encounter Each scale is designed to function independently Patients can thus be asked to complete some or all of a module s BREAST
21. g J Beber B Pusic AL Hofer SO Patient satisfaction and health related quality of life after autologous tissue breast reconstruction A prospective analysis of early postoperative outcomes Cancer 2011 Oct 24 Jeevan R Cromwell D Browne J van der Meulen J Caddy CM Pereira J Sheppard C et al Fourth Annual Report of the National Mastectomy and Breast Reconstruction Audit 2011 Leeds The NHS Information Centre 2011 http www ic nhs uk mbr McCarthy CM Cano SJ Klassen AF Scott AM VanLaeken NY Lennox PA Cordeiro PG Pusic AL The Magnitude of Effect of Cosmetic Breast Augmentation on Patient Satisfaction and Health Related Quality of Life Plast Reconstr Surg Accepted Suggested further reading about patient reported outcomes in plastic surgery Cano SJ Klassen A Pusic AL The science behind quality of life measurement a primer for plastic surgeons Plast Reconstr Surg 2009 Mar 123 3 98e 106e Rubin L Klassen AF Cano SJ Hurley K Pusic AL Motivations for breast surgery a qualitative comparison study of breast reconstruction augmentation and reduction patients The Breast Journal 2009 Nov Dec 15 6 666 7 Epub 2009 Sep 7 Spector D Mayer D Knafl K Pusic A Not What I Expected Informational Needs of Women Undergoing Breast Surgery Plastic Surgical Nursing April June 2010 Vol 30 2 70 74 Winters Z E Benson J R Pusic A L A Systematic Review of the Clinical Evidence to Guide Treatment Recommendations in Bre
22. itive International Translation Translation Review Debriefing Harmonization Not French applicable German Nol applicable US Spanish applicable Swedish nius E E applicable Not Italian applicable UK English Not a applicable Not Norwegian applicable Polish Not applicable Not Slovenian applicable denotes academic translations supervised by MAPI institute www BREAST Q org BREAST Q User Manual Version 1 0 July 2012 The specific methodology used to produce the versions of the BREAST Q Reconstruction module is summarized in the table below Linguistic validation process Language Forward Backward Adaptation Clinician s Cognitive International Translation Translation Review Debriefing Harmonization Not French applicable German Not applicable US Spanish Not applicable Dutch for Not Belgium applicable French for Not Belgium applicable Russian for Not Armenia applicable Not Icelandic applicable Dutch for Not Netherlands applicable Not Norwegian applicable Polish Not applicable Not
23. k when clothed or unclothed There are also postoperative only items e g location and appearance of scars Satisfaction with Nipples This scale measures satisfaction with the appearance of the nipple and areola complex Items cover their location on the breast symmetry shape and nipple sensation Satisfaction with Outcome This scale measures a woman s overall appraisal of the outcome of her breast surgery Items cover whether the woman s expectations were met with respect to the aesthetic outcome and the impact surgery has had upon her life as well as satisfaction with the decision to have surgery e g I would do it Satisfaction with Care a Information This scale measures satisfaction with information provided about breast reduction surgery from the surgeon Items cover complications and risks e g loss of nipple sensation implications for future breast cancer screening and breast feeding healing and recovery time how the surgery would be done and breast appearance e g breast size scars b Surgeon This scale measures satisfaction with the surgeon Items ask about the surgeon s manner e g professional reassuring thorough sensitive and communication skills e g easy to talk to Items also cover the extent to which the patient was involved in the decision making and understood the process c Medical Team This scale measures satisfaction with members of the medical team other than surgeo
24. members of the office staff Items ask whether staff were professional knowledgeable and friendly as well as how comfortable the woman was made to feel and whether she felt she was treated in a respectful manner www BREAST Q org BREAST Q User Manual Version 1 0 July 2012 1 2 BREAST Q REDUCTION MASTOPEXY MODULE APPENDIX 3 amp 4 QUALITY OF LIFE DOMAINS Psychosocial Well being This scale measures psychosocial well being with items that ask about body image e g accepting of body attractive and a woman s confidence in social settings Other items cover emotional health and self esteem Sexual Well being This scale measures sexual well being and body image issues with items that ask about feelings of sexual attractiveness when clothed and unclothed and sexual confidence as it relates to one s breasts as well as how comfortable or at ease a woman feels during sexual activity Physical Well being Chest and Upper Body This scale captures physical problems caused by breast size including pain e g breast shoulder back neck energy level rashes and sleeping problems There are also questions asking about activity limitations and balance SATISFACTION DOMAINS Satisfaction with Breasts This scale measures body image in terms of a woman s satisfaction with her breasts Items cover breast appearance e g size symmetry softness cleavage and satisfaction with breasts in relation to how a bra fits and how the breasts loo
25. n Items ask whether the staff were professional knowledgeable and friendly as well as how comfortable the woman was made to feel and whether she felt she was treated in a respectful manner d Office Staff This scale measures satisfaction with interactions with members of the office staff Items ask whether staff were professional knowledgeable and friendly as well as how comfortable the woman was made to feel and whether she felt she was treated in a respectful manner www BREAST Q org BREAST Q User Manual Version 1 0 July 2012 1 3 BREAST Q MASTECTOMY MODULE APPENDIX 7 amp 8 QUALITY OF LIFE DOMAINS 1 Psychosocial Well being This scale measures psychosocial well being with items that ask about body image e g accepting of body attractive and a woman s confidence in social settings Other items cover emotional health and self esteem 2 Sexual Well being This scale measures sexual well being and body image issues with items that ask about feelings of sexual attractiveness when clothed and unclothed and sexual confidence as it relates to one s breasts as well as how comfortable or at ease a woman feels during sexual activity 3 Physical Well being a Chest and Upper Body This scale captures negative physical sequelae of the chest and upper body There are questions about shoulder neck back arm chest muscle and rib pain There are also questions about breast area discomfort such as tightness pulling nagging te
26. n introductory paragraph at the beginning of the questionnaire The BREAST Q is available in paper and pencil format an electronic version is in development 3 Scoring Instructions for Scoring BREAST Q data using QScore Q Score its accompanying manual and data entry templates are available to download from http webcore mskcc org breastq scoreBQ html To score BREAST Q data using QScore 1 Select the appropriate QScore Excel template corresponding to the version of the BREAST Q module you need scored For example if you ve been administering the BREAST Q Postoperative Augmentation Module choose the Post op Augmentation Template for data entry ns mu M uo es Insert Page Layout Formulas Data Review View Add Ins Post op BREAST Q Augmentation Template opened in Excel 2 The second row of each template indicates the valid numerical values allowed for each scale A value of 88 should be entered if more than one answer choice was selected on the questionnaire 66 if the non applicable N A option was selected and 99 for all missing information A B D F G H J K hv Satisfaction with Breasts Values 1 4 88 99 are valid Export to QScore Important Avoid making any changes to the first three rows of the template Any change to this area will cause errors when the data is imported to QScore 3 When entering your data make sure there are no empty c
27. nd greater than 20 as very much change Interpretative data on individual patients scores is not available but longitudinal assessment at multiple time points should establish a personal norm for each individual patient Then changes over time for an individual patient may be best judged in relation to what is normal for that patient It is also expected that as QL measurement becomes more common in clinical settings intuitive familiarity will develop both through individual and collective experience as has occurred for more established measures of disease activity and severity For more information about the BREAST Q we direct the reader to Section 8 Further Reading 5 Technical Data A description of the development and validation of the BREAST Q is available in Appendix 9 From BREAST Q to Q Score Using Rasch Measurement to better capture breast surgery outcomes Cano SJ Pusic AL Klassen A Proceedings from the Joint International IMEKO TC1 TC7 TC13 Symposium 90 102 2011 For more information about the BREAST Q we direct the reader to Section 8 Further Reading www BREAST Q org BREAST Q User Manual 6 Translations Version 1 0 July 2012 The specific methodology used to produce the versions of the BREAST Q Augmentation module is summarized in the table below Linguistic validation process Language Forward Backward Adaptation Clinician s Cogn
28. nderness aching and throbbing There are also questions asking about activity limitations and balance b Abdomen and Trunk This scale captures negative physical sequelae of the abdomen Items cover abdominal discomfort bloating and pain as well as difficulty doing certain activities due to abdominal weakness There is a single item asking about abdomen appearance SATISFACTION DOMAINS 1 Satisfaction with Breasts This scale measures body image in terms of a woman s satisfaction the breast area and asks questions regarding how comfortably bras fit and how satisfied a woman is with her breast area both clothed and unclothed 2 Satisfaction with Care a Surgeon This scale measures satisfaction with the surgeon Items ask about the surgeon s manner e g professional reassuring thorough sensitive and communication skills e g easy to talk to Items also cover the extent to which the patient was involved in the decision making and understood the process b Medical team This scale measures satisfaction with members of the medical team other than surgeon Items ask whether the staff were professional knowledgeable and friendly as well as how comfortable the woman was made to feel and whether she felt she was treated in a respectful manner c Office Staff This scale measures satisfaction with interactions with members of the office staff Items ask whether staff were professional knowledgeable and friendly as well as how
29. nswer the questions based on their own understanding of the items What should I do if a patient asks why the BREAST Q has to be filled out on more than one occasion if administering the BREAST Q prospectively Explain that patients must complete the same BREAST Q at additional visits in order to see if their answers change with time This will give a more complete picture of how a her health related quality of life and satisfaction changes over time Frequently Asked Questions Scoring of the BREAST Q How do I score the BREAST Q In order to achieve high quality data the BREAST Q data must be scored appropriately using QScore software It is crucial that raw responses provided by patients be transformed into BREAST Q scores using the Q Score program This program is provided free of charge on our Web site www BREAST Q org Using this program researchers and clinicians are able to convert their raw questionnaire data into summary scores for each BREAST Q scale Scores will range from 0 to 100 with a higher number indicating higher satisfaction or better quality of life The transformation is essential as it is through this process that the ordinal level data are linearized by means of item calibrations Using Q Score researchers may then compare their sample of patients with patients from different studies that have also used the BREAST Q as all will be on a common metric Is there one total score for the BREAST Q No there is no summ
30. odification to the content of the BREAST Q by deleting an item within a scale is not acceptable There are three main reasons why deleting items is not allowed The first is that deleting items from the BREAST Q would nullify the psychometric properties of BREAST Q scales The second reason is that by deleting items it would then not be possible to score the BREAST Q and you would not be able to compare findings with those of other BREAST Q studies Finally deleting items is prohibited under copyright laws Can I change the wording of any item in the BREAST Q No you cannot change any items BREAST Q scale Any modification to the content of the BREAST Q by changing an item within a scale is not acceptable There are three main reasons why changing items is not allowed The first is that altering the wording of items in the BREAST Q would nullify the psychometric properties of BREAST Q scales The second reason is by modifying items it would then not be possible to score the BREAST Q and you would not be able to compare findings with those of other BREAST Q studies Finally changing the wording of items is prohibited under copyright laws Can I add any items to the BREAST Q No you cannot add any items to a BREAST Q scale Any modification to the content of the BREAST Q by adding items to a scale is not acceptable There are three main reasons why adding items is not acceptable The first is that adding items to the BREAST Q would nullify the
31. ple ScoredBreastQ xls select All files from the Save type drop down list c Click Save to complete the export process My Computer File 1 ScoredBreastO xs 3 My Network Save as type 2 files v R 11 The Output File area in QScore now indicates the directory where the scored data has been saved 34 34 36 Output File F Breast Manual 4ugmentation ScoredBreastl xls 12 Exit QScore Opening QScore output in Excel 1 Open the Excel spread sheet exported from QScore A dialog box will appear with the following The file you are trying to open FILE is in a different format than specified by the file extension Verify that the file is not corrupted and is from a trusted source before opening the file Do you want to open the file now Select yes Microsoft Office Excel Verify that the file is not corrupted and is from a trusted source before opening the file Do you want to open the File now The file you are trying to open ScoredBreastQ xls is a different Format than specified by the File extension Note This message appears because the file is still being read as a text file www BREAST Q org BREAST Q User Manual Version 1 0 July 2012 2 The scored data is now opened and formatted for easy viewing in Excel c Micr z Fw 5 2 Home Insert Page Layout Formulas Data R
32. rgery What about expectation www BREAST Q org BREAST Q User Manual Version 1 0 July 2012 1 1 BREAST Q AUGMENTATION MODULE APPENDIX 1 amp 2 QUALITY OF LIFE DOMAINS Psychosocial Well being This scale measures psychosocial well being with items that ask about body image e g accepting of body attractive and a woman s confidence in social settings Other items cover emotional health and self esteem Sexual Well being This scale measures sexual well being and body image issues with items that ask about feelings of sexual attractiveness when clothed and unclothed and sexual confidence as it relates to one s breasts as well as how comfortable or at ease a woman feels during sexual activity Physical Well being Chest and Upper Body This scale captures negative physical sequelae of the chest and upper body There are questions about symptoms of pain or tightness in the breast area as well as difficulty with mobility e g lifting arms and doing activities e g running lifting SATISFACTION DOMAINS Satisfaction with Breasts This scale measures body image in terms of a woman s satisfaction with her breasts Items cover breast appearance e g size symmetry softness implant placement cleavage and satisfaction with breasts in relation to how a bra fits and how the breasts look when clothed or unclothed There are also items specific to implants e g rippling and postoperative issues e g scars S
33. rms of a woman s satisfaction with her breasts and asks questions regarding how comfortably bras fit and how satisfied a woman is with her breast area both clothed and unclothed Postoperative items ask about breast appearance e g size symmetry softness and clothing issues e g how bras fit being able to wear fitted clothes There are also implant specific items e g amount of rippling that can be seen or felt 2 Satisfaction with Nipples This scale measures satisfaction with the appearance of the reconstructed nipple and areola complex Items cover shape colour projection and how natural the reconstructed nipple looks 3 Satisfaction with Abdomen This scale measures patient satisfaction with abdominal appearance following autologous tissue breast reconstruction TRAM or DIEP flap Items ask about overall appearance as well as position of navel belly button and scars 4 Satisfaction with Outcome This scale measures a woman s overall appraisal of the outcome of her breast surgery Items cover whether the woman s expectations were met with respect to the aesthetic outcome and the impact surgery has had upon her life as well as satisfaction with the decision to have surgery e g I would do it again 5 Satisfaction with Care a Information This scale measures satisfaction with information provided about breast reconstruction surgery from the surgeon Items cover types of breast reconstruction complications and risks
34. ructures are used 1 Expectations for Support from Medical Staff This scale measures how much time and emotional support the patient is expecting from the medical team and surgeon 2 Expectations for Pain This scale measures the magnitude of pain the patient is expecting to experience in the first week after reconstruction surgery 3 Expectations for Recovery This scale measures patient expectations regarding their recovery and return to normal activities in the first week after surgery 4 Expectations for Coping This scale measures how a patient is anticipating she will cope with the process of breast reconstruction during the first year after surgery 5 Expectations for Breast Appearance and Outcome This scale measures how a patient expects her breasts to look one year after surgery 6 Expectations for Psychosocial Well being This scale measures how a patient expects to feel about herself one year after breast reconstruction 7 Expectations for Sexual Well being This scale measures how a patient expects she will feel sexually one year after breast reconstruction www BREAST Q org BREAST Q User Manual Version 1 0 July 2012 2 Administration of the BREAST Q The BREAST Q is a self administered questionnaire An entire BREAST Q module can be completed in about 10 15 minutes Each scale takes 1 4 minutes to complete No specific training is required to complete any module of the BREAST Q Patients are given instructions in a
35. stectomy 4 Reconstruction A fifth module the BREAST Q Breast Conserving Therapy BCT module is in development for women undergoing lumpectomy with and without radiation for the treatment of breast cancer All BREAST Q modules are based on an underlying conceptual framework developed from extensive qualitative research with breast surgery patients close examination of the research literature and engagement of healthcare professionals working with breast surgery patients Data collected from all three of these sources was used to formulate a breast surgery conceptual framework The conceptual framework of the four BREAST Q modules is comprised of two overarching themes or domains These are 1 Patient Satisfaction and 2 Health related Quality of Life QOL Under each of these domains there are six subthemes i e QOL Physical Psychosocial and Sexual well being patient Patient Satisfaction Satisfaction with breasts Satisfaction with overall outcome and Satisfaction with Care see Figure 1 Body image is an important concept for breast surgery patients This concept is measured by several of our BREAST Q scales see detailed descriptions of items for each scale starting on Page 7 All four modules have the same conceptual framework with the exception of the Reconstruction module which also includes the additional theme of Patient Expectations Physical Psychosocial Sexual Well being Well being Well being www BREAST Q or
36. t available the translation guidelines for linguistic validation and translation PROinformation mapi trust org http www mapi trust org services questionnairelicensing cataloguequestionnaires 1 1 1 breast q Frequently Asked Questions Administering the BREAST Q Who helps patients to complete the questionnaire in clinic The BREAST Q scales were designed for self completion Are there specific time points when patients complete the scales A researcher or clinician can decide the time points pre and post operatively he or she would like to administer the scales Each module of the BREAST Q has a pre operative and post operative version The post operative version includes all the pre operative items in addition to items that address unique postoperative issues e g scars Is there an electronic version I can use or can I code a version for online administration with my patients A validated electronic version of the BREAST Q is in development Please contact the authors for the availability Can I automate my own scoring system for online data collection A webserver system for real time scoring is currently in development Please contact the authors for the availability of this online system Frequently Asked Questions Patient questions about the BREAST Q What should I do if the patient refuses to fill out the BREAST Q For research purposes patients have the right to refuse to participate in a study If the BREAST Q is
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